An adaptive, phase II, dose-finding clinical trial design to evaluate L-carnitine in the treatment of septic shock based on efficacy and predictive probability of subsequent phase III success.

Septic shock patients remain at high risk for morbidity and mortality. Lewis and colleagues report the planned use of an adaptive clinical trial design to evaluate the potential benefits of L-carnitine in patients with septic shock. This manuscript describes the trial design and clinical endpoints of the proposed trial and the performed computer modeling of potential outcomes; it may be of interest to clinicians who wish to better...

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